RecruitingPhase 2Phase 3NCT04982419

Remote Ischemic Preconditioning for Renal and Cardiac Protection in Congestive Heart Failure (RICH) Trial


Sponsor

VA Office of Research and Development

Enrollment

240 participants

Start Date

Nov 1, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

This is a prospective, double-blind, sham-controlled, multicenter, randomized clinical trial is to study the effects of remote ischemic preconditioning on contrast-associated acute kidney injury, functional capacity, and major adverse kidney events in in patients with congestive heart failure undergoing cardiac catheterization and/or percutaneous coronary intervention.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a technique called remote ischemic preconditioning (RIPC) — brief, controlled squeezing of the arm with a blood pressure cuff — to see if it protects the kidneys and heart in heart failure patients undergoing coronary angiography (a procedure that uses dye to look at heart arteries) or a stenting procedure. **You may be eligible if...** - You are 18 or older - You have heart failure with reduced pumping function (ejection fraction below 50%) - You are scheduled for a coronary angiogram or stenting procedure - Your risk of kidney injury from the procedure is above 1% **You may NOT be eligible if...** - You are unable to give consent - You have very high or very low blood pressure at enrollment - You have peripheral artery disease in your arms, or only one usable arm - You are on dialysis or have had a kidney transplant - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICERemote ischemic preconditioning

3 cycles of blood pressure cuff inflations to occlusive pressure of 200 mmHg for 5 minutes and deflation for 5 minutes

DEVICESham remote ischemic conditioning

3 cycles of blood pressure cuff inflations to non-occlusive pressure of 60 mmHg for 5 minutes and deflation for 5 minutes (Control)


Locations(3)

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Pittsburgh, Pennsylvania, United States

VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

Dallas, Texas, United States

Hunter Holmes McGuire VA Medical Center, Richmond, VA

Richmond, Virginia, United States

View Full Details on ClinicalTrials.gov

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NCT04982419


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